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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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Primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. Also the study will explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.
Determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms than placebo in persons with Bipolar Depression (BPD), depressed phase. In our pilot study, pregnenolone showed a strong signal on depression scores.
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnenolone | Active Comparator | This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks. |
|
| Placebo | Placebo Comparator | The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnenolone | Drug | Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 17-item Hamilton Rating Scale for Depression (HRSD17) | The HRSD is an observer-rated measure of depressive symptomatology. Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inventory of Depressive Symptomatology-Self Report (IDS-SR) | IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode. Score: Minimum: 0 Maximum: 84 Lower score associated with better outcome | 12 weeks |
| Young Mania Rating Scale (YMRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edson S Brown, MD/PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnenolone | This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks. Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system. |
| FG001 | Placebo | The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks. Placebo: Inactive ingredient matching the active medication in appearance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnenolone | This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks. Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The 17-item Hamilton Rating Scale for Depression (HRSD17) | The HRSD is an observer-rated measure of depressive symptomatology. Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnenolone | This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks. Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal ulceration | Eye disorders | Non-systematic Assessment |
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Sample size; treatment groups not well matched on gender or depressive symptom scores
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| E. Sherwood Brown, MD, PhD | University of Texas Southwestern Medical Center | 2146466948 | sherwood.brown@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| D011284 | Pregnenolone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Placebo | Drug | Inactive ingredient matching the active medication in appearance. |
|
|
This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). Score: Minimum: 0 Maximum: 60 Lower score associated with better outcome |
| 12 weeks |
| Hamilton Rating Scale for Anxiety (HRSA) | The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where less than 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | 12 weeks |
| BG001 |
| Placebo |
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks. Placebo: Inactive ingredient matching the active medication in appearance. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Bipolar Diagnosis | Participants were graded clinically by using the Diagnostic and Statistical Manual of Mental Disorders (DSM) guidelines for criteria from a structured clinical interview. | Number | participants |
|
| Age of onset of mood symptoms | Mean | Standard Deviation | years |
|
| Concomitant Medications: Lithium | Number | participants |
|
| Concomitant Medications: Anticonvulsant | Number | participants |
|
| Concomitant Medications: Antidepressant | Number | participants |
|
| Concomitant Medications: Antipsychotic | Number | participants |
|
| Concomitant Medications: Sedative/hypnotic/anxiolytic | Number | participants |
|
| Concomitant medications: Stimulant | Number | participants |
|
| Concomitant medications: None | Number | participants |
|
| Hamilton Rating Scale for Depression (HRSD) | Minimum: 0 Maximum: 50 Better outcome: lower Normal= 7 or less | Mean | Standard Deviation | units on a scale |
|
| Inventory of Depressive Symtomatology-Self Report (IDS-SR) | Minimum: 0 Maximum: 84 Better outcome: Lower Normal: 7 or less | Mean | Standard Deviation | units on a scale |
|
| Young Mania Rating Scale (YMRS) | Minimum: 0 Maximum: 60 Better outcome: lower | Mean | Standard Deviation | units on a scale |
|
| Hamilton Rating Scale for Anxiety (HRSA) | Minimum: 0 Maximum: 56 Better outcome: lower | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Inventory of Depressive Symptomatology-Self Report (IDS-SR) | IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode. Score: Minimum: 0 Maximum: 84 Lower score associated with better outcome | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Young Mania Rating Scale (YMRS) | This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). Score: Minimum: 0 Maximum: 60 Lower score associated with better outcome | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Hamilton Rating Scale for Anxiety (HRSA) | The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where less than 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
|
| 4 |
| 38 |
| 0 |
| 38 |
| EG001 | Placebo | The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks. Placebo: Inactive ingredient matching the active medication in appearance. | 3 | 35 | 0 | 35 |
| Skin abscess followed by allergic reaction to antibiotic used to treat it | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Injuries secondary to motor vehicle accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D002241 | Carbohydrates |